BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM

    MDR report key: 10307856 · Received July 22, 2020

    Report

    Report Number
    8030965-2020-05113
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Date of Event
    July 2, 2020
    Report Date
    July 3, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTW
    UDI-DI
    07611819775398
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H6: PART:03.010.103, SYNTHES LOT: 4L97683, SUPPLIER LOT: N/A, RELEASE TO WAREHOUSE DATE: MAY 29, 2019, EXPIRATION DATE: N/A, MANUFACTURED BY SYNTHES GMBH. NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON PLACED A POLAR SCREW AND PERFORMED A BONE DRILLING. HE LEFT THE DRILL BIT WHEN DRILLING THE INTRAMEDULLARY CAVITY. THE TIP OF THE DRILL BIT THAT WAS ANCHORED TO THE BONE WAS SPLIT. THE BIT AND TIP WERE REMOVED. NO FRAGMENTS OF THE DRILL BIT REMAINED IN THE BONE CAVITY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771249 3.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM BIT, DRILL HTW OBERDORF SYNTHES PRODUKTIONS GMBH 4L97683 07611819775398

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR UNK - POWERED DRIVERS/HANDPIECES| UNK - SCREWS: TRAUMA| UNK - POWERED DRIVERS/HANDPIECES| UNK - SCREWS: TRAUMA